Effect of Vitamin D Intake in Pregnancy to Prevent Recurrence of Gestational Diabetes

NCT ID: NCT03701087

Last Updated: 2018-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

430 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-02

Study Completion Date

2020-04-02

Brief Summary

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primary outcome is vitamin D intake in first trimester for pregnant women with history of gestational diabetes in previous pregnancies and incidence of gestational diabetes recurrence secondary outcome is effect of vitamin D intake on mode of delivery, apgar score and neonatal birth weight

Detailed Description

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it is a prospective randomized controlled study to determined the effect of vitamin D supplementation in pregnancy in reducing the incidence of gestational diabetes recurrence. it will be conducted at the department of obstetrics and gynecology kasr el ainy hospital faculty of medicine Cairo university from August 2018 to April 2020. we include in our study 430 pregnant women who had history of gestational diabetes in their previous pregnancies. patients with multiple pregnancy or with any medical disorder are excluded from study. BMI will be calculated for each participant at the time of admission and glucose challenge test will be performed for all patients in the first trimester to exclude diabetic patients from the study then a blood sample is taken from all patients enrolled in the study to measure the vitamin D level by ELISA (after fasting 12 hours and not have a fatty dinner) the participants will be assigned to one of three main groups according to the serum 25 OH vitamin D level. pregnant women with normal vitamin D level assigned as group A, pregnant women with lower serum level of vitamin D (\>20 nmol/L) randomly divided into two groups: group B and C. Group B will be given oral vitamin D 2800 units daily till 26 week pregnancy and group C will be given Omega 3 as placebo till 26 week pregnancy. incidence of gestational diabetes will be measured in 24-26 week pregnancy with OGTT and compared in the three groups. All patients will be followed up till delivery. Mode of delivery, Apgar score and neonatal birth weight will be recorded.

Conditions

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Vitamin D Intake in First Trimester and Incidence of Gestational Diabetes Recurrence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Effect of Vitamin D intake in pregnancy to prevent recurrence of gestational Diabetes
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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normal serum vitamin D

normal serum vitamin D

Group Type NO_INTERVENTION

No interventions assigned to this group

low serum level of vitamin D

this arm will intake vitamin D 2800 IU daily

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

2800 IU daily till 26 weeks of pregnancy

low serum vitamin D

this arm will intake placebo omega 3

Group Type PLACEBO_COMPARATOR

Vitamin D

Intervention Type DRUG

2800 IU daily till 26 weeks of pregnancy

Interventions

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Vitamin D

2800 IU daily till 26 weeks of pregnancy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* pregnant women with history of gestational diabetes in previous pregnancies

Exclusion Criteria

* multiple pregnancy
* pregnant patient with medical disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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hadeer meshal

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ashraf mohsen, lecturer

Role: PRINCIPAL_INVESTIGATOR

Investigator

Locations

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Kasr El Ainy

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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hany saad, Ass Prof

Role: CONTACT

01001817211

hadeer meshaal, Ass prof

Role: CONTACT

01001435238

Facility Contacts

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mohamed saad, lecturer

Role: primary

01244336666

Other Identifiers

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assistant professor

Identifier Type: -

Identifier Source: org_study_id

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